(167 days)
The VASOVIEW HEMOPRO System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and perioheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW HEMOPRO Harvesting Tool for cutting and sealing of vessel branches. The C-Ring/distal lens washer is independently controlled by a C-Ring Slider on the handle of the device that retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be extended/retracted from the main cannula by inserting it into the Tool Adapter Port, and rotated independently. The Harvesting Tool has two curved Jaws. One Jaw contains the heating elements for branch cutting and sealing; the second Jaw is longer and has a serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the HEMOPRO Jaws, and (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
This document describes a 510(k) submission for the MAQUET VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, seeking substantial equivalence to a predicate device (K052274). The submission focuses on device modifications to address specific Medical Device Report (MDR) issues related to self-activation/overheating. Since this is a submission for substantial equivalence based on modifications to an existing device, the "acceptance criteria" and "device performance" are primarily demonstrated through specific performance and safety testing, rather than novel clinical performance metrics against a medical condition.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the types of tests conducted and the conclusion that the device's functionality and performance characteristics are "comparable" to the predicate device. The document does not explicitly state numerical acceptance thresholds for these tests, but rather indicates that the tests successfully demonstrated comparable performance and addressed the identified issues.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance Testing (General functionality comparable to predicate) | The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed VASOVIEW HemoPro Endoscopic Vessel Harvesting System. These tests addressed MDR issues identified as self-activated/remains activated and overheating. |
| Burst Pressure Testing | Performed during development. Implied to meet safety standards comparable to the predicate. |
| Thermal Spread Testing | Performed during development. Implied to meet safety standards comparable to the predicate. |
| Electrical Testing (60601-1) | Performed during development. Implied to meet 60601-1 standards, which address safety requirements for medical electrical equipment. |
| Shelf Life Testing | Performed during development. Implied to ensure the device maintains functionality and sterility over its intended shelf life. |
| Substantial Equivalence | The device is found substantially equivalent to the currently marketed predicate device (K052274) based on similar intended use and fundamental scientific technology, with performance and other testing establishing equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for the "in-vitro tests" conducted. The provenance of the data is not explicitly stated beyond being "in-vitro tests." This typically implies laboratory testing using simulated conditions or excised tissue, rather than human clinical data. The document focuses on bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The study is an in-vitro engineering and performance verification study, not a clinical study requiring expert ground truth for diagnostic or clinical outcome evaluation.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human subject data and multiple reviewers to reach a consensus on diagnoses or outcomes. This document describes technical device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This submission is for a physical medical device (endoscopic vessel harvesting system), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness metrics would be part of this type of submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. As mentioned above, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the performance and safety tests, the "ground truth" would be established by the test standards and specifications themselves. For example, for "burst pressure testing," the ground truth is the specified pressure the device must withstand without failure. For "electrical testing 60601-1," the ground truth is compliance with the detailed requirements of the ISO 60601-1 standard. There is no biological "ground truth" in the sense of pathology or outcomes data in this in-vitro testing context.
8. The Sample Size for the Training Set
This information is not applicable and not provided. Training sets are relevant for machine learning or AI algorithms. This is a traditional medical device submission.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.